This disclosure relates to systems for analyzing biological fluids. In particular, this disclosure relates to an analytic system in which one or more components of the system are modular in nature and connectable to a fluidic network via standardized connectors.
As biological diagnostics have increased in complexity over the past decades, there has been a trend for diagnostics and testing equipment to be removed from points of care, such as a physician's office, and moved to centralized laboratory service locations. At least in part, this trend was due to perceived problems in quality control stemming from performing testing at various points of care with traditional diagnostic technology. For example, in comparison to a large medical center with a sizable staff of highly skilled technicians, a small town physician's office with a small independent lab was believed to lack the oversight and technical support necessary to properly operate and service complicated laboratory equipment.
Such trends have been reinforced by federal legislation and regulations, such as those imposed by the Clinical Laboratory Improvement Act (CLIA) of 1988, despite protests from physicians' organizations. From 1988 forward, many physician office laboratories were closed, as they were unable to comply with the requirements of the CLIA. As of 2011, more than 90% of all diagnostics testing was performed in centralized laboratories.
While this centralized approach may have been a solution for controlling the quality of diagnostic information considering the technology at the time, it is not without its problems. Perhaps the greatest problem is that patients in medically underserved areas, which are primarily served by physicians operating out of small or mobile offices, now had reduced access to important diagnostic testing. Test samples either needed to be collected and transported (which can present potential additional cost and handling) or patients needed to travel to a centralized laboratory facility to have tests performed (which may require that patients living in rural environments travel a great distance, which can dissuade some patients from having the test performed at all due to the cost or the time associated with travel).
Very recently, some attempts have been made to move more diagnostic testing back to or towards the point of care. However, their limited adoption reveals the many challenges of moving testing to the point of care in the current healthcare environment. Among the problems are that most current point of care solutions either significantly sacrifice quality to try to compete with centralized laboratory services on cost (for example, most lab-on-a-chip designs have a target price point that requires significant tradeoffs between cost and performance) or are not particularly economical as a whole (for example, multiple systems are required for various types of analytes and many physicians must still rely a centralized laboratory to meet at least some of their routine testing needs).
Still further, most point of care laboratories have separate systems for different diagnostic tests. At a small or medium sized testing facility, it can be hard to justify the expense of separate systems for different types of tests where testing volume is relatively low. Further, selecting a suite of efficient devices is often difficult as there is often redundant, unshared hardware across the various devices yet, due to differences in the device interfaces, middleware must still be obtained to integrate and connect the various devices into a single laboratory information system. At the same time, having multiple testing devices takes up significant laboratory real estate and can mean separate systems to operate and maintain, separate contracts to manage, and separate manufacturers and vendors. Thus, even with the high desirability of a return to point of care diagnostics testing, currently there has been very limited adoption of this model.
Hence, a need exists for improved administration of diagnostic testing. Among other things, there is a strong need for improved distribution and servicing of reliable diagnostics equipment at mid- and small-sized points of care.